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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000218-12 | EudraCT Number |
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| Name | Class |
|---|---|
| Novartis Vaccines | INDUSTRY |
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Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to <72 Months of Age. The study was conducted during the 2013/2014 and 2014/2015 northern hemisphere influenza season.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aQIV | Experimental | flu vaccine |
|
| non-adjuvanted comparator | Active Comparator | flu vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV) | Biological | 1 or 2 doses (naïve / non-naive subjects) 0.25 ml: ≥6 months to <36 months, 0.5 ml: ≥36 months to <72 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Endpoint: First-Occurrence Reverse Transcription-Polymerase Chain Reaction (RT-PCR) Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age | Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects ≥6 to <72 months of age with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season, whichever was longer. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial). | ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. | Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season, whichever was longer. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Program Director | Seqirus | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 222, Novartis Investigational Site | Chandler | Arizona | 85224 | United States | ||
| 267, Novartis Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32404782 | Derived | Esposito S, Fling J, Chokephaibulkit K, de Bruijn M, Oberye J, Zhang B, Vossen J, Heijnen E, Smolenov I. Immunogenicity and Safety of an MF59-adjuvanted Quadrivalent Seasonal Influenza Vaccine in Young Children at High Risk of Influenza-associated Complications: A Phase III, Randomized, Observer-blind, Multicenter Clinical Trial. Pediatr Infect Dis J. 2020 Aug;39(8):e185-e191. doi: 10.1097/INF.0000000000002727. | |
| 29631857 |
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All enrolled subjects were included in the trial. Non-naive participants received 1 dose of vaccine on Day 1 only. Naive participants received 2 doses of vaccine, the first dose on Day 1 and the second dose on Day 29.
Subjects were enrolled from 146 sites in 9 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | aQIV (≥6 to <72 Months) | Subjects ≥6 to <72 months of age who received aQIV |
| FG001 | TIV/QIV (≥6 to <72 Months) | Subjects ≥6 to <72 months of age who received TIV/QIV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Non-adjuvanted Trivalent Influenza Vaccine (TIV) / Quadrivalent Influenza Vaccine (QIV) | Biological | 1 or 2 doses (naïve / non-naive subjects) 0.25 ml: ≥6 months to <36 months, 0.5 ml: ≥36 months to <72 months |
|
| ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer |
| Efficacy Endpoint: First-Occurrence Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months, ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age | Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects with culture confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season, whichever was longer. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial). | ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer |
| Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects at High Risk of Influenza Complications | Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects ≥6 to <72 months of age with RT-PCR confirmed and culture confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season, whichever was longer, in healthy subjects and subjects at risk of influenza related complications. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial). | ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer |
| Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Naive and Non-naive Subjects Separately | Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season, whichever was longer. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial). | ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer |
| Efficacy Endpoint: First-occurrence RT-PCR-confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age at ≥7 Days and at ≥14 Days After First Vaccination up to the Day of Second Vaccination in Vaccine naïve Subjects Only | Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was based on the number of vaccine naive subjects ≥6 to <72 months of age with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥7 days and ≥14 days after the first vaccination up to the day of the second vaccination. TIV was used as the comparator in Season 1; and QIV was used as the comparator in Season 2. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial). | ≥7 days and at ≥14 days after first vaccination up to day of second vaccination |
| Efficacy Endpoint: First-occurrence RT-PCR-confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age Occurring at ≥7 Days and ≤21 Days After Last Vaccination, in All Subjects. | Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was based on the number of vaccine naïve subjects ≥6 to <72 months of age with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥7 days and ≤21 after the last vaccination. TIV was used as the comparator in Season 1; and QIV was used as the comparator in Season 2. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial). | ≥7 days and ≤21 days after the last vaccination |
| Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age | Pooled GMT values across both naïve and non-naïve subjects are provided for the Day 22/50 (ie, 21 days after last vaccination) and Day 181/209 (ie, 180 days after last vaccination) assessments; Nonadjuvanted TIV administered in Season 1 and nonadjuvanted QIV administered in Season 2; Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/ Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; For B/Victoria results from Season 2 only are presented for both vaccine groups and used in the vaccine comparison analysis. | Baseline (Day 1), Day 29, Day 50 and Day 209 for vaccine naïve subjects; Baseline (Day 1), Day 22 and Day 181 for vaccine non-naïve subjects |
| Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) in Vaccine Naive Subjects ≥6 to <72 Months of Age | GMTs for vaccine naïve subjects are provided by strain for Day 29 and Day 50; Nonadjuvanted TIV administered in Season 1 and nonadjuvanted QIV administered in Season 2; Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/ Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; For B/Victoria results from Season 2 only are presented for both vaccine groups and used in the vaccine comparison analysis. | Day 29 and Day 50 |
| Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age | HI GMT was assessed on Day 1 and Day 50 for vaccine naïve healthy vs high risk subjects; and HI GMT were assessed on Day 1 and Day 22 for vaccine non-naïve healthy vs high risk subjects; pooled GMT values across both naïve and non-naïve subjects are provided for Day 22/50 (ie, 21 days after last vaccination) assessments. | Baseline (Day 1) and 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects) |
| Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Ratios (GMR) in Subjects ≥6 to <72 Months of Age | The fold-increase in HI antibodies in response to vaccination was assessed as the GMR between all post-vaccination titers (ie, Day 29, 50, 209 for vaccine naïve subjects; Day 22, 181 for vaccine non-naïve subjects) and the baseline (Day 1) titer. Assessed GMRs thus correspond to Day 29/Day 1, Day 50/Day 1, and Day 209/Day 1 for vaccine naïve subjects and Day 22/Day 1 and Day 181/Day 1 for vaccine non-naïve subjects. Pooled GMR values across both naïve and non-naïve subjects are provided for Day (22/50)/Day 1 (ie, 21 days after last vaccination) and Day (181/209)/Day 1 (ie, 180 days after last vaccination); Nonadjuvanted TIV administered in Season 1 and nonadjuvanted QIV administered in Season 2; Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; For B/Victoria results from Season 2 only are presented for both vaccine groups and used in the vaccine comparison analysis. | Baseline (Day 1), Day 29, Day 50 and Day 209 for vaccine naïve subjects; Baseline (Day 1), Day 22 and Day 181 for vaccine non-naïve subjects |
| Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Seroconversion (SC) Rates and Difference in SC Rates at 21 Days in Subjects ≥6 to <72 Months of Age | SC rates were assessed on Day 1 and Day 50 (ie, 21 days after two vaccinations) for vaccine naïve subjects; and on Day 1 and Day 22 (ie, 21 days after one vaccination) for vaccine non-naïve subjects; values pooled across naive and non-naive subjects are provided. Seroconversion is defined as HI ≥ 1:40 for subjects negative at baseline (ie, HI titer<1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (ie, HI titer ≥ 1:10); Nonadjuvanted TIV administered in Season 1 and nonadjuvanted QIV administered in Season 2; Homologous strain: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; For B/Victoria results from Season 2 only are presented for both vaccine groups and used in the vaccine. comparison analysis (N=745 for aQIV, N=738 for comparator). | Baseline (Day 1) and 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects) |
| Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titer ≥ 1:40 and Percentage Differences at 180 Days After Last Vaccination in Subjects ≥6 to <72 Months of Age | Antibody response was assessed as the percentage of subjects with HI titer of ≥1:40 at 180 days after last vaccination (ie, Day 209 for vaccine naïve subjects and Day 181 for vaccine non-naïve subjects). Results were then pooled across both vaccine naïve and non-naïve subjects. Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; B/Victoria results from Season 1 and Season 2 (aQIV) and Season 2 (comparator) are presented. | Baseline (Day 1) and 180 days after the last vaccination (Day 209 for vaccine naive subjects; Day 181 for vaccine non-naïve subjects) |
| Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | Antibody response was assessed as the percentage of subjects and differences of percentage of subjects with HI titers of ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 at 21 days after last vaccination (ie, Day 50 for vaccine naïve subjects and Day 22 for vaccine non-naïve subjects). Results were then pooled across both vaccine naïve and non-naïve subjects. Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; B/Victoria results from Season 1 and Season 2 (aQIV) and Season 2 (comparator) are presented. | Baseline (Day 1) and 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects) |
| Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Geometric Mean Titers (GMTs) in Subjects ≥6 to <72 Months of Age | HI GMT was assessed 21 days after last vaccination (Day 50 for vaccine naïve subjects and Day 22 for vaccine non-naive subjects) pooled GMT values across both naïve and non-naïve subjects are provided for the Day 22/50 (ie, 21 days after last vaccination); Heterologous strains: H1N1=A/Brisbane/59/2007- like; H3N2 =A/Hong Kong/4801/2014; B/Yamagata=B/Phuket/3073/2013-like; B Victoria=B/Malaysia/2506/2004; For B/Victoria results from Season 2 only are presented for both vaccine groups. | 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects) |
| Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Heterologous Strains in Terms of Seroconversion (SC) Rates in Subjects ≥6 to <72 Months of Age | SC rates were assessed on Day 50 (ie, 21 days after two vaccinations) for vaccine naïve subjects; and on Day 22 (ie, 21 days after one vaccination) for vaccine non-naïve subjects; values pooled across naive and non-naive subjects are provided. Seroconversion is defined as HI ≥ 1:40 for subjects negative at baseline (ie, HI titer<1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (ie, HI titer ≥ 1:10); Heterologous strains include: H1N1=A/Brisbane/59/2007- like; H3N2 =A/Hong Kong/4801/2014; B/Yamagata=B/Phuket/3073/2013- like; B Victoria=B/Malaysia/2506/2004; For B/Victoria results from Season 2 only are presented for both vaccine groups | 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects) |
| Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Percentage of Subjects With HI Titer ≥ 1:40 in Subjects ≥6 to <72 Months of Age | Antibody persistence was assessed as the percentage of subjects with HI titer of ≥1:40 at 21 days after last vaccination (ie, Day 50 for vaccine naïve subjects and Day 22 for vaccine non-naïve subjects). Results were then pooled across both vaccine naïve and non-naïve subjects; Heterologous strains: H1N1=A/Brisbane/59/2007- like; H3N2 =A/Hong Kong/4801/2014; B/Yamagata=B/Phuket/3073/2013- like; B Victoria=B/Malaysia/2506/2004; For B/Victoria results from Season 2 only are presented for both vaccine groups. | 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects) |
| Safety Endpoint: Number of Subjects With Solicited Local and Systemic AEs | Subjects ≥6 to <72 months of age reporting solicited local and systemic reactions, day 1 to day 7 after vaccination with either aQIV or TIV/QIV. | 7 days following each vaccination |
| Safety Endpoint: Number of Subjects With Unsolicited AEs, SAEs, AEs Leading to Withdrawal From the Study or Study Vaccination, NOCDs and AESIs | Safety was assessed in terms of number of subjects ≥6 to <72 months of age reporting unsolicited reactions (Day 1 to Day 50 for vaccine naïve subjects and from Day 1 to Day 22 for vaccine non-naïve subjects); Serious Adverse Events (SAEs), AEs leading to New Onset of Chronic Diseases,(NOCD), Adverse Events of Special Interests (AESI), AEs leading to withdrawal from the study or study vaccination after vaccination with either aQIV or TIV/QIV were collected up to 12 months after last vaccination. | Day 1 though Day 366 (vaccine non-naive)/Day 390 (vaccine naive) |
| Healthcare Utilization and Health Economic Endpoints: Number of Days of Daycare, School or Preschool Missed by Subjects Associated With RT-PCR-confirmed Influenza | within a window of 14 days after influenza-like illness (ILI)-onset |
| Healthcare Utilization and Health Economic Endpoint: Number of Medical Visit for Respiratory Illness Associated With RT-PCR-confirmed Influenza | within a window of 14 days after ILI-onset |
| Healthcare Utilization and Health Economic Endpoint: Number of Employment Days Missed by Parent(s)/Guardian(s) of Subjects With RT-PCR-confirmed Influenza | within a window of 14 days after ILI-onset |
| Healthcare Utilization and Health Economic Endpoint: First-occurrence of RT-PCR-confirmed Moderate-to-severe Influenza Cases as Per Prespecified Criteria in Subjects ≥6 to <72 Months of Age in Season 2. | ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer |
| Harrisburg |
| Arkansas |
| 72432 |
| United States |
| 259, Novartis Investigational Site | Anaheim | California | 92801 | United States |
| 280, Novartis Investigational Site | Anaheim | California | 92804 | United States |
| 213, Novartis Investigational Site | Baldwin Park | California | 91706 | United States |
| 407, Novartis Investigational Site | Downey | California | 90241 | United States |
| 238, Novartis Investigational Site | La Puente | California | 91774 | United States |
| 411, Novartis Investigational Site | Ontario | California | 91762 | United States |
| 202, Novartis Investigational Site | Paramount | California | 90723 | United States |
| 250, Novartis Investigational Site | San Diego | California | 92103 | United States |
| 293, Novartis Investigational Site | San Francisco | California | 94102 | United States |
| 243, Novartis Investigational Site | Colorado Springs | Colorado | 80902 | United States |
| 249, Novartis Investigational Site | Denver | Colorado | 80902 | United States |
| 229, Novartis Investigational Site | Boca Raton | Florida | 33432 | United States |
| 416, Novartis Investigational Site | Hialeah | Florida | 33013 | United States |
| 287, Novartis Investigational Site | Hialeah | Florida | 33106 | United States |
| 412, Novartis Investigational Site | Homestead | Florida | 34239 | United States |
| 224, Novartis Investigational Site | Melbourne | Florida | 32935 | United States |
| 417, Novartis Investigational Site | Miami | Florida | 33015 | United States |
| 404, Novartis Investigational Site | Miami | Florida | 33144 | United States |
| 285, Novartis Investigational Site | Miami | Florida | 33172 | United States |
| 277,Novartis Investigational Site | Miami | Florida | 33412 | United States |
| 234, Novartis Investigational Site | Opa-locka | Florida | 33054 | United States |
| 297, Novartis Investigational Site | Orlando | Florida | 32801 | United States |
| 297, Novartis Investigational vaccine | Orlando | Florida | 32806 | United States |
| 410, Novartis Investigational Site | Sarasota | Florida | 34239 | United States |
| 401, Novartis iNvestiagtional Site | Atlanta | Georgia | 30322 | United States |
| 299, Novartis Investigational Site | DeKalb | Illinois | 60115 | United States |
| 268, Novartis Investigational Site | Peoria | Illinois | 61602 | United States |
| 209, Novartis Investigational Site | Augusta | Kansas | 67010 | United States |
| 210, Novartis Investigational Site | Newton | Kansas | 67114 | United States |
| 274 Novartis Investigational Site | Park City | Kansas | 67219 | United States |
| 211, Novartis Investigational Site | Wichita | Kansas | 67205 | United States |
| 269, Novartis Investigational Site | Bardstown | Kentucky | 40004 | United States |
| 226, Novartis Investigational Site | Louisville | Kentucky | 40202 | United States |
| 248, Novartis Investigational Site | Louisville | Kentucky | 40217 | United States |
| 207, Novartis Investigational Site | Louisville | Kentucky | 40291 | United States |
| 290, Novartis Investigational Site | Louisville | Kentucky | 40291 | United States |
| 265, Novartis Investigational Site | Haughton | Louisiana | 71037 | United States |
| 408, Novartis Investigational Site | Mangham | Louisiana | 71259 | United States |
| 225, Novartis Investigational Site | Metairie | Louisiana | 70006 | United States |
| 233, Novartis Investigational Site | Metairie | Louisiana | 70006 | United States |
| 418, Novartis Investigational SIte | Monroe | Louisiana | 71201 | United States |
| 262, Novartis Investigational site | Annapolis | Maryland | 21401 | United States |
| 263, Novartis Investigational Site | Frederick | Maryland | 21702 | United States |
| 405, Novartis Investigational Site | Silver Spring | Maryland | 20910 | United States |
| 278, Novartis Investigational Site | Saint Paul | Minnesota | 55108 | United States |
| 221, Novartis Investigational Site | Bellevue | Nebraska | 68005 | United States |
| 219, Novartis Investigational Site | Fremont | Nebraska | 68025 | United States |
| 402, Novartis Investigational Site | Omaha | Nebraska | 68114 | United States |
| 288, Novartis Investigational Site | Omaha | Nebraska | 68131 | United States |
| 228, Novartis Investigational Site | Omaha | Nebraska | 68134 | United States |
| 244, Novartis Investigational Site | Henderson | Nevada | 89014 | United States |
| 286, Novartis Investigational site | Las Vegas | Nevada | 89106 | United States |
| 255, Novartis Investigational Site | Binghamton | New York | 13901 | United States |
| 414, Novartis Investigational Site | Brooklyn | New York | 11201 | United States |
| 264, Novartis Investigational Site | Syracuse | New York | 13057 | United States |
| 409, Novartis Investigational Site | Boone | North Carolina | 28607 | United States |
| 266, Novartis Investigational Site | Cary | North Carolina | 27518 | United States |
| 403, Novartis Investigational Site | Clyde | North Carolina | 28721 | United States |
| 240, Novartis Investigational Site | Akron | Ohio | 44311 | United States |
| 254, Novartis Investigational Site | Cleveland | Ohio | 44122 | United States |
| 245, Novartis Investigational Site | Dayton | Ohio | 45406 | United States |
| 281, Novartis Investigational Site | Dayton | Ohio | 45409 | United States |
| 281, Novartis Investigational vaccines | Dayton | Ohio | 45409 | United States |
| 256, Novartis Investigational Site | Tulsa | Oklahoma | 74127 | United States |
| 292, Novartis Investigational Site | Erie | Pennsylvania | 16505 | United States |
| 270, Novartis Investigational Site | Scottdale | Pennsylvania | 15683 | United States |
| 220, Novartis Investigational Site | Anderson | South Carolina | 29621 | United States |
| 406, novartis Investigational Site | Barnwell | South Carolina | 29812 | United States |
| 272, Novartis Investigational Site | Charleston | South Carolina | 29407 | United States |
| 232, Novartis Investigational Site | Moncks Corner | South Carolina | 29461 | United States |
| 291, Novartis Investigational vaccine | Spartanburg | South Carolina | 27262 | United States |
| 283, Novartis Investigational Site | Nashville | Tennessee | 37203 | United States |
| 208, Novartis Investigational Site | Austin | Texas | 78705 | United States |
| 247, Novartis Investigational Site | Fort Worth | Texas | 76107 | United States |
| 217, Novartis Investigational Site | Fort Worth | Texas | 76135 | United States |
| 214, Novartis Investigational Site | San Angelo | Texas | 76904 | United States |
| 400, Novartis investigational Site | San Antonio | Texas | 78229 | United States |
| 260, Novartis Investigational Site | Tomball | Texas | 77375 | United States |
| 295, Novartis Investigational Site | Layton | Utah | 84041 | United States |
| 236, Novartis Investigational Site | Salt Lake City | Utah | 84109 | United States |
| 212, Novartis Investigational Site | Salt Lake City | Utah | 84121 | United States |
| 246, Novartis Investigational Site | Salt Lake City | Utah | 84124 | United States |
| 279, Novartis Investigational Site | Spanish Fork | Utah | 84660 | United States |
| 282, Novartis Investigational Site | Syracuse | Utah | 84075 | United States |
| 294, Novartis Investigational Site | West Haven | Utah | 84401 | United States |
| 201, Novartis Investigational Site | West Jordan | Utah | 84088 | United States |
| 271, Novartis Investigational Site | West Jordan | Utah | 84088 | United States |
| 251, Novartis Investigational Site | Burke | Virginia | 22015 | United States |
| 296, Novartis Investigational Site | Vienna | Virginia | 22180 | United States |
| 184, Novartis Investigational Site | Greater Sudbury | Ontario | P3E 1H5 | Canada |
| 180, Novartis Investigational Site | Newmarket | Ontario | L3Y 5G8 | Canada |
| 182,Novartis Investigational Site | Toronto | Ontario | M9V 4B4 | Canada |
| 183, Novartis Investigational Site | Québec | G1E 7G9 | Canada |
| 186, Novartis Investigational Site | Québec | Canada |
| 001, Novartis Investigational Site | Espoo | FI-02230 | Finland |
| 003, Novartis Investigational Site | Helsinki | FIN-00100 | Finland |
| 002, Novartis Investigational Site | Helsinki | FIN-00930 | Finland |
| 004, Novartis Investigational Site | Jarvenpaa | FIN-04400 | Finland |
| 005, Novartis Investigational Site | Kokkola | FI-67100 | Finland |
| 006, Novartis Investigational Site | Oulu | 90220 | Finland |
| 007, Novartis Investigational Site | Pori | FI-28100 | Finland |
| 008, Novartis Investigational Site | Seinäjoki | FI-60100 | Finland |
| 009, Novartis Investigational Site | Tampere | FIN-33100 | Finland |
| 010, Novartis Investigational Site | Turku | FIN-20520 | Finland |
| 011, Novartis Investigational Site | Vantaa | FIN-01300 | Finland |
| 030, Novartis Investigational Site | Florence | 50139 | Italy |
| 023, Novartis Investigational Site | Genova | 16132 | Italy |
| 020, Novartis Investigational Site | Milan | 20122 | Italy |
| 026, Novartis Investigational Site | Milan | 20157 | Italy |
| 025, Novartis Investigational Site | Naples | 80131 | Italy |
| 021, Novartis Investigational Site | Novara | 28100 | Italy |
| 022, Novartis Investigational Site | Padova | 35128 | Italy |
| 024, Novartis Investigational Site | Pisa | 56126 | Italy |
| 028, Novartis Investigational Site | Sassari | 07100 | Italy |
| 173, Novartis Investigational Site | Morelia | Michoacán | 58070 | Mexico |
| 176, Novartis Investigational Site | Durango | 34000 | Mexico |
| 170, Novartis Investigational Site | México | 04530 | Mexico |
| 177, Novartis Investigational Site | México | 06760 | Mexico |
| 178, Novartis Investigational Site | México | 14000 | Mexico |
| 175, Novartis Investigational Site | México | 7020 | Mexico |
| 300, Novartis Investigational Site | Dasmariñas | Cavite | 4114 | Philippines |
| 306, Novartis Investigational Site | Alabang | Muntilupa | 1781 | Philippines |
| 303, Novartis Investigational Site | City of Muntinlupa | 1781 | Philippines |
| 304, Novartis Investigational Site | City of Muntinlupa | 1781 | Philippines |
| 305, Novartis Investigational Site | City of Muntinlupa | 1781 | Philippines |
| 302, Novartis Investigational Site | Manila | 1000 | Philippines |
| 301, Novartis Investigational Site | Manila | 1001 | Philippines |
| 040, Novartis Investigational Site | Dębica | 39-200 | Poland |
| 042, Novartis Investigational Site | Katowice | 40-018 | Poland |
| 048, Novartis Investigational Site | Lodz | 91347 | Poland |
| 049, Novartis Investigational Site | Lubartów | 21-100 | Poland |
| 051, Novartis Investigational Site | Oborniki Śląskie | 55-120 | Poland |
| 046, Novartis Investigational Site | Osielsko | 86-031 | Poland |
| 043, Novartis Investigational Site | Siemianowice Śląskie | 41-103 | Poland |
| 047, Novartis Investigational Site | Tarnów | 33-100 | Poland |
| 041, Novartis Investigational Site | Warsaw | 01809 | Poland |
| 050, Novartis Investigational Site | Warsaw | 04-730 | Poland |
| 045, Novartis Investigational Site | Wola | 43-225 | Poland |
| 044, Novartis Investigational Site | Wroclaw | 51215 | Poland |
| 052, Novartis Investigational Site | Łęczna | 21-010 | Poland |
| 257, Novartis Investigational Site | Ponce | 00716 | Puerto Rico |
| 415, Novartis Investigational vaccine | San Juan | 00909 | Puerto Rico |
| 415, Novartis Investigational Site | San Juan | 00921 | Puerto Rico |
| 80, Novartis Investigational Site | Sabadell | Barcelona | 08208 | Spain |
| 075, Novartis Investigational Site | Santiago de Compostela | Galicia | 15701 | Spain |
| 074, Novartis Investigational Site | Granada | 18009 | Spain |
| 076, Novartis Investigational Site | Madrid | 28041 | Spain |
| 077, Novartis Investigational Site | Madrid | 28046 | Spain |
| 79, Novartis Investigational Site | Málaga | 29011 | Spain |
| 078, Novartis Investigational Site | Valencia | 46026 | Spain |
| 343, Novartis Investigational Site | Banqiao District | New Taipei City | 220 | Taiwan |
| 346, Novartis Investigational Site | Datong | Taipei City | 10341 | Taiwan |
| 344, Novartis Investigational Site | Taichung | 40447 | Taiwan |
| 345, Novartis Investigational Site | Taichung | 40705 | Taiwan |
| 340, Novartis Investigational Site | Taipei | 10041 | Taiwan |
| 341, Novartis Investigational Site | Taipei | 10449 | Taiwan |
| 342, Novartis Investigational Site | Taoyuan | 333 | Taiwan |
| 321, Novartis Investigational Site | Bangkoknoi | Bangkok | 10700 | Thailand |
| 322, Novartis Investigational Site | Bangkoknoi | Bangkok | 10700 | Thailand |
| 323, Novartis Investigational Site | Pathum Wan | Bangkok | 10330 | Thailand |
| 327, Novartis Investigational Site | Ratchathewi | Bangkok | 10400 | Thailand |
| 325, Novartis Investigational Site | Pathum Thani | Changwat Pathum Thani | 12120 | Thailand |
| 326, Novartis Investigational Site | Hat Yai | Songkhia | 90110 | Thailand |
| 320, Novartis Investigational Site | Bangkok | 10400 | Thailand |
| 324, Novartis Investigational Site | Bangkok | 10400 | Thailand |
| Derived |
| Vesikari T, Kirstein J, Devota Go G, Leav B, Ruzycky ME, Isakov L, de Bruijn M, Oberye J, Heijnen E. Efficacy, immunogenicity, and safety evaluation of an MF59-adjuvanted quadrivalent influenza virus vaccine compared with non-adjuvanted influenza vaccine in children: a multicentre, randomised controlled, observer-blinded, phase 3 trial. Lancet Respir Med. 2018 May;6(5):345-356. doi: 10.1016/S2213-2600(18)30108-5. Epub 2018 Apr 6. |
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | aQIV (≥6 to <72 Months) | Subjects ≥6 to <72 months of age who received aQIV |
| BG001 | TIV/QIV (≥6 to <72 Months) | Subjects ≥6 to <72 months of age who received TIV/QIV |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Naivety Status | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Efficacy Endpoint: First-Occurrence Reverse Transcription-Polymerase Chain Reaction (RT-PCR) Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age | Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects ≥6 to <72 months of age with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season, whichever was longer. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial). | The Full Analysis Set for Efficacy consisting of all enrolled subjects who actually received a study vaccination and were evaluated for efficacy at least 21 days after the last vaccination was used for analysis. | Posted | Number | Number of cases | ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer |
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| Secondary | Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. | Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season, whichever was longer. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial). | The Full Analysis Set for Efficacy consisting of all enrolled subjects who actually received a study vaccination and were evaluated for efficacy at least 21 days after the last vaccination was used for analysis. | Posted | Number | Number of cases | ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer |
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| Secondary | Efficacy Endpoint: First-Occurrence Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months, ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age | Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects with culture confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season, whichever was longer. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial). | The Full Analysis Set for Efficacy consisting of all enrolled subjects who actually received a study vaccination and were evaluated for efficacy at least 21 days after the last vaccination was used for analysis. | Posted | Number | Number of cases | ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer |
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| Secondary | Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects at High Risk of Influenza Complications | Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects ≥6 to <72 months of age with RT-PCR confirmed and culture confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season, whichever was longer, in healthy subjects and subjects at risk of influenza related complications. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial). | The Full Analysis Set for Efficacy consisting of all enrolled subjects who actually received a study vaccination and were evaluated for efficacy at least 21 days after the last vaccination was used for analysis. | Posted | Number | Number of cases | ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer |
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| Secondary | Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Naive and Non-naive Subjects Separately | Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season, whichever was longer. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial). | The Full Analysis Set for Efficacy consisting of all enrolled subjects who actually received a study vaccination and were evaluated for efficacy at least 21 days after the last vaccination was used for analysis. | Posted | Number | Number of cases | ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer |
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| Secondary | Efficacy Endpoint: First-occurrence RT-PCR-confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age at ≥7 Days and at ≥14 Days After First Vaccination up to the Day of Second Vaccination in Vaccine naïve Subjects Only | Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was based on the number of vaccine naive subjects ≥6 to <72 months of age with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥7 days and ≥14 days after the first vaccination up to the day of the second vaccination. TIV was used as the comparator in Season 1; and QIV was used as the comparator in Season 2. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial). | Full Analysis Set Early Efficacy: All subjects in the Enrolled Set who actually received a study vaccination and were evaluated for efficacy at least 7 days after the last vaccination. | Posted | Number | Number of cases | ≥7 days and at ≥14 days after first vaccination up to day of second vaccination |
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| Secondary | Efficacy Endpoint: First-occurrence RT-PCR-confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age Occurring at ≥7 Days and ≤21 Days After Last Vaccination, in All Subjects. | Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was based on the number of vaccine naïve subjects ≥6 to <72 months of age with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥7 days and ≤21 after the last vaccination. TIV was used as the comparator in Season 1; and QIV was used as the comparator in Season 2. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial). | Full Analysis Set Early Efficacy: All subjects in the Enrolled Set who actually received a study vaccination and were evaluated for efficacy at least 7 days after the last vaccination. | Posted | Number | Number of cases | ≥7 days and ≤21 days after the last vaccination |
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| Secondary | Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age | Pooled GMT values across both naïve and non-naïve subjects are provided for the Day 22/50 (ie, 21 days after last vaccination) and Day 181/209 (ie, 180 days after last vaccination) assessments; Nonadjuvanted TIV administered in Season 1 and nonadjuvanted QIV administered in Season 2; Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/ Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; For B/Victoria results from Season 2 only are presented for both vaccine groups and used in the vaccine comparison analysis. | The Full Analysis Set for Immunogenicity consisting of all enrolled/randomized subjects who received a study vaccination AND provided evaluable serum samples (immunogenicity) for both before (baseline) and after vaccination was used for analysis. | Posted | Geometric Mean | 95% Confidence Interval | titer | Baseline (Day 1), Day 29, Day 50 and Day 209 for vaccine naïve subjects; Baseline (Day 1), Day 22 and Day 181 for vaccine non-naïve subjects |
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| Secondary | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) in Vaccine Naive Subjects ≥6 to <72 Months of Age | GMTs for vaccine naïve subjects are provided by strain for Day 29 and Day 50; Nonadjuvanted TIV administered in Season 1 and nonadjuvanted QIV administered in Season 2; Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/ Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; For B/Victoria results from Season 2 only are presented for both vaccine groups and used in the vaccine comparison analysis. | The Full Analysis Set for Immunogenicity consisting of all enrolled/randomized subjects who received a study vaccination AND provided evaluable serum samples (immunogenicity) for both before (baseline) and after vaccination was used for analysis. | Posted | Geometric Mean | 95% Confidence Interval | titer | Day 29 and Day 50 |
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| Secondary | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age | HI GMT was assessed on Day 1 and Day 50 for vaccine naïve healthy vs high risk subjects; and HI GMT were assessed on Day 1 and Day 22 for vaccine non-naïve healthy vs high risk subjects; pooled GMT values across both naïve and non-naïve subjects are provided for Day 22/50 (ie, 21 days after last vaccination) assessments. | The Full Analysis Set for Immunogenicity consisting of all enrolled/randomized subjects who received a study vaccination AND provided evaluable serum samples (immunogenicity) for both before (baseline) and after vaccination was used for analysis. | Posted | Geometric Mean | 95% Confidence Interval | titer | Baseline (Day 1) and 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects) |
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| Secondary | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Ratios (GMR) in Subjects ≥6 to <72 Months of Age | The fold-increase in HI antibodies in response to vaccination was assessed as the GMR between all post-vaccination titers (ie, Day 29, 50, 209 for vaccine naïve subjects; Day 22, 181 for vaccine non-naïve subjects) and the baseline (Day 1) titer. Assessed GMRs thus correspond to Day 29/Day 1, Day 50/Day 1, and Day 209/Day 1 for vaccine naïve subjects and Day 22/Day 1 and Day 181/Day 1 for vaccine non-naïve subjects. Pooled GMR values across both naïve and non-naïve subjects are provided for Day (22/50)/Day 1 (ie, 21 days after last vaccination) and Day (181/209)/Day 1 (ie, 180 days after last vaccination); Nonadjuvanted TIV administered in Season 1 and nonadjuvanted QIV administered in Season 2; Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; For B/Victoria results from Season 2 only are presented for both vaccine groups and used in the vaccine comparison analysis. | The Full Analysis Set for Immunogenicity consisting of all enrolled/randomized subjects who received a study vaccination AND provided evaluable serum samples (immunogenicity) for both before (baseline) and after vaccination was used for analysis. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Baseline (Day 1), Day 29, Day 50 and Day 209 for vaccine naïve subjects; Baseline (Day 1), Day 22 and Day 181 for vaccine non-naïve subjects |
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| Secondary | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Seroconversion (SC) Rates and Difference in SC Rates at 21 Days in Subjects ≥6 to <72 Months of Age | SC rates were assessed on Day 1 and Day 50 (ie, 21 days after two vaccinations) for vaccine naïve subjects; and on Day 1 and Day 22 (ie, 21 days after one vaccination) for vaccine non-naïve subjects; values pooled across naive and non-naive subjects are provided. Seroconversion is defined as HI ≥ 1:40 for subjects negative at baseline (ie, HI titer<1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (ie, HI titer ≥ 1:10); Nonadjuvanted TIV administered in Season 1 and nonadjuvanted QIV administered in Season 2; Homologous strain: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; For B/Victoria results from Season 2 only are presented for both vaccine groups and used in the vaccine. comparison analysis (N=745 for aQIV, N=738 for comparator). | The Full Analysis Set for Immunogenicity consisting of all enrolled/randomized subjects who received a study vaccination AND provided evaluable serum samples (immunogenicity) for both before (baseline) and after vaccination was used for analysis. | Posted | Number | 95% Confidence Interval | percentage of subjects | Baseline (Day 1) and 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects) |
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| Secondary | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titer ≥ 1:40 and Percentage Differences at 180 Days After Last Vaccination in Subjects ≥6 to <72 Months of Age | Antibody response was assessed as the percentage of subjects with HI titer of ≥1:40 at 180 days after last vaccination (ie, Day 209 for vaccine naïve subjects and Day 181 for vaccine non-naïve subjects). Results were then pooled across both vaccine naïve and non-naïve subjects. Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; B/Victoria results from Season 1 and Season 2 (aQIV) and Season 2 (comparator) are presented. | The Full Analysis Set for Immunogenicity consisting of all enrolled/randomized subjects who received a study vaccination AND provided evaluable serum samples (immunogenicity) for both before (baseline) and after vaccination was used for analysis. | Posted | Number | 95% Confidence Interval | percentage of subjects | Baseline (Day 1) and 180 days after the last vaccination (Day 209 for vaccine naive subjects; Day 181 for vaccine non-naïve subjects) |
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| Secondary | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | Antibody response was assessed as the percentage of subjects and differences of percentage of subjects with HI titers of ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 at 21 days after last vaccination (ie, Day 50 for vaccine naïve subjects and Day 22 for vaccine non-naïve subjects). Results were then pooled across both vaccine naïve and non-naïve subjects. Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; B/Victoria results from Season 1 and Season 2 (aQIV) and Season 2 (comparator) are presented. | The Full Analysis Set for Immunogenicity consisting of all enrolled/randomized subjects who received a study vaccination AND provided evaluable serum samples (immunogenicity) for both before (baseline) and after vaccination was used for analysis. | Posted | Number | 95% Confidence Interval | percentage of subjects | Baseline (Day 1) and 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects) |
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| Secondary | Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Geometric Mean Titers (GMTs) in Subjects ≥6 to <72 Months of Age | HI GMT was assessed 21 days after last vaccination (Day 50 for vaccine naïve subjects and Day 22 for vaccine non-naive subjects) pooled GMT values across both naïve and non-naïve subjects are provided for the Day 22/50 (ie, 21 days after last vaccination); Heterologous strains: H1N1=A/Brisbane/59/2007- like; H3N2 =A/Hong Kong/4801/2014; B/Yamagata=B/Phuket/3073/2013-like; B Victoria=B/Malaysia/2506/2004; For B/Victoria results from Season 2 only are presented for both vaccine groups. | The Full Analysis Set for Immunogenicity consisting of all enrolled/randomized subjects who received a study vaccination AND provided evaluable serum samples (immunogenicity) for both before (baseline) and after vaccination was used for analysis. | Posted | Geometric Mean | 95% Confidence Interval | titer | 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects) |
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| Secondary | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Heterologous Strains in Terms of Seroconversion (SC) Rates in Subjects ≥6 to <72 Months of Age | SC rates were assessed on Day 50 (ie, 21 days after two vaccinations) for vaccine naïve subjects; and on Day 22 (ie, 21 days after one vaccination) for vaccine non-naïve subjects; values pooled across naive and non-naive subjects are provided. Seroconversion is defined as HI ≥ 1:40 for subjects negative at baseline (ie, HI titer<1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (ie, HI titer ≥ 1:10); Heterologous strains include: H1N1=A/Brisbane/59/2007- like; H3N2 =A/Hong Kong/4801/2014; B/Yamagata=B/Phuket/3073/2013- like; B Victoria=B/Malaysia/2506/2004; For B/Victoria results from Season 2 only are presented for both vaccine groups | The Full Analysis Set for Immunogenicity consisting of all enrolled/randomized subjects who received a study vaccination AND provided evaluable serum samples (immunogenicity) for both before (baseline) and after vaccination was used for analysis. | Posted | Number | 95% Confidence Interval | percentage of subjects | 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects) |
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| Secondary | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Percentage of Subjects With HI Titer ≥ 1:40 in Subjects ≥6 to <72 Months of Age | Antibody persistence was assessed as the percentage of subjects with HI titer of ≥1:40 at 21 days after last vaccination (ie, Day 50 for vaccine naïve subjects and Day 22 for vaccine non-naïve subjects). Results were then pooled across both vaccine naïve and non-naïve subjects; Heterologous strains: H1N1=A/Brisbane/59/2007- like; H3N2 =A/Hong Kong/4801/2014; B/Yamagata=B/Phuket/3073/2013- like; B Victoria=B/Malaysia/2506/2004; For B/Victoria results from Season 2 only are presented for both vaccine groups. | The Full Analysis Set for Immunogenicity consisting of all enrolled/randomized subjects who received a study vaccination AND provided evaluable serum samples (immunogenicity) for both before (baseline) and after vaccination was used for analysis. | Posted | Number | 95% Confidence Interval | percentage of subjects | 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects) |
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| Secondary | Safety Endpoint: Number of Subjects With Solicited Local and Systemic AEs | Subjects ≥6 to <72 months of age reporting solicited local and systemic reactions, day 1 to day 7 after vaccination with either aQIV or TIV/QIV. | The Solicited Safety Set consisting of all subjects who received a study vaccination and had any assessment of local and systemic reactions and/or assessment of any use of analgesics/antipyretics was used for analysis. | Posted | Count of Participants | Participants | 7 days following each vaccination |
|
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| Secondary | Safety Endpoint: Number of Subjects With Unsolicited AEs, SAEs, AEs Leading to Withdrawal From the Study or Study Vaccination, NOCDs and AESIs | Safety was assessed in terms of number of subjects ≥6 to <72 months of age reporting unsolicited reactions (Day 1 to Day 50 for vaccine naïve subjects and from Day 1 to Day 22 for vaccine non-naïve subjects); Serious Adverse Events (SAEs), AEs leading to New Onset of Chronic Diseases,(NOCD), Adverse Events of Special Interests (AESI), AEs leading to withdrawal from the study or study vaccination after vaccination with either aQIV or TIV/QIV were collected up to 12 months after last vaccination. | The Unsolicited Safety Set consisting of all subjects who received a study vaccination and had any AE assessments was used for analysis (ie, a subject did not have to have an AE to be included in this population). | Posted | Count of Participants | Participants | Day 1 though Day 366 (vaccine non-naive)/Day 390 (vaccine naive) |
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| Secondary | Healthcare Utilization and Health Economic Endpoints: Number of Days of Daycare, School or Preschool Missed by Subjects Associated With RT-PCR-confirmed Influenza | Full Analysis Set Health Economic Outcomes (Season 2): This analysis set includes all subjects in the Enrolled Set in Season 2 who: actually received a study vaccination and provided efficacy data and Health Economic data collected within 14 days of ILI-onset; and had a first-occurrence RT-PCR-confirmed influenza as included in the primary efficacy objective. | Posted | Mean | Standard Deviation | Number of days | within a window of 14 days after influenza-like illness (ILI)-onset |
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| Secondary | Healthcare Utilization and Health Economic Endpoint: Number of Medical Visit for Respiratory Illness Associated With RT-PCR-confirmed Influenza | Full Analysis Set Health Economic Outcomes (Season 2): This analysis set includes all subjects in the Enrolled Set in Season 2 who: actually received a study vaccination and provided efficacy data and Health Economic data collected within 14 days of ILI-onset; and had a first-occurrence RT-PCR-confirmed influenza as included in the primary efficacy objective. | Posted | Mean | Standard Deviation | Number of visits | within a window of 14 days after ILI-onset |
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| Secondary | Healthcare Utilization and Health Economic Endpoint: Number of Employment Days Missed by Parent(s)/Guardian(s) of Subjects With RT-PCR-confirmed Influenza | Full Analysis Set Health Economic Outcomes (Season 2): This analysis set includes all subjects in the Enrolled Set in Season 2 who: actually received a study vaccination and provided efficacy data and Health Economic data collected within 14 days of ILI-onset; and had a first-occurrence RT-PCR-confirmed influenza as included in the primary efficacy objective. | Posted | Mean | Standard Deviation | Number of days | within a window of 14 days after ILI-onset |
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| Secondary | Healthcare Utilization and Health Economic Endpoint: First-occurrence of RT-PCR-confirmed Moderate-to-severe Influenza Cases as Per Prespecified Criteria in Subjects ≥6 to <72 Months of Age in Season 2. | Full Analysis Set Health Economic Outcomes (Season 2) | Posted | Number | Number of cases | ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer |
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|
Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole.
SAEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects.
Non-serious AEs: solicited AEs: Day 1 to Day 7 after each vaccination; and unsolicited AEs: Day 1 to Day 366 for vaccine non-naive and Day 1 to Day 390 for vaccine naive subjects.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | aQIV (≥6 to <72 Months) | Subjects ≥6 to <72 months of age who received aQIV | 1 | 5,339 | 234 | 5,243 | 4,627 | 5,339 |
| EG001 | TIV/QIV (≥6 to <72 Months) | Subjects ≥6 to <72 months of age who received TIV/QIV | 3 | 5,272 | 230 | 5,161 | 4,430 | 5,272 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Kawasaki's disease | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Acute lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Ependymoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Allergy to arthropod bite | Immune system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Allergy to arthropod sting | Immune system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Type I hypersensitivity | Immune system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Accidental exposure to product | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Animal scratch | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Burns second degree | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Chemical burn of gastrointestinal tract | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Exposure to toxic agent | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Foreign body | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Gun shot wound | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Tongue injury | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Traumatic liver injury | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Vulvovaginal injury | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Ankyloglossia congenital | Congenital, familial and genetic disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dacryostenosis congenital | Congenital, familial and genetic disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Heart disease congenital | Congenital, familial and genetic disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Adenoidal hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Asthmatic crisis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Status asthmaticus | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Immune thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Autism | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Encephalitis autoimmune | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Coeliac disease | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Incarcerated inguinal hernia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Intussusception | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Post streptococcal glomerulonephritis | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Henoch-Schonlein purpura | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Lichen sclerosus | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Papule | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Device malfunction | Product Issues | MedDRA 19.1 | Systematic Assessment |
| |
| Fasciitis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hyperaldosteronism | Endocrine disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal wall abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Abscess jaw | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Adenovirus infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Amoebiasis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Amoebic dysentery | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Brain abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Breast abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Cellulitis staphylococcal | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Cholera | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Corona virus infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Croup infectious | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Exanthema subitum | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Gastritis viral | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Gastroenteritis rotavirus | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Gastroenteritis salmonella | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Groin abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Herpangina | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Infectious mononucleosis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Laryngitis viral | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Mastoiditis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Meningitis aseptic | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Meningitis bacterial | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Mycoplasma infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Periorbital cellulitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonia adenoviral | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonia chlamydial | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonia mycoplasmal | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Staphylococcal scalded skin syndrome | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Typhoid fever | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Viral diarrhoea | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Viral pharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Viral rash | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Viral sinusitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Injection site inflammation | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Eating disorder | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Study Disclosure Manager | Seqirus | Seqirus.ClinicalTrials@Seqirus.com |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Vaccine Non-Naive |
|
| A/H3N2 |
|
| B/Yamagata |
|
| B/Victoria |
|
Subjects ≥6 to <24 months of age who received TIV/QIV
| OG002 | aQIV (≥6 to <36 Months) | Subjects ≥6 to <36 months of age who received aQIV |
| OG003 | TIV/QIV (≥6 to <36 Months) | Subjects ≥6 to <36 months of age who received TIV/QIV |
| OG004 | aQIV (≥36 to <72 Months) | Subjects ≥36 to <72 months of age who received aQIV |
| OG005 | TIV/QIV (≥36 to <72 Months) | Subjects ≥36 to <72 months of age who received TIV/QIV |
|
|
Subjects ≥6 to <72 months of age who received TIV/QIV
| OG002 | aQIV (≥6 to <24 Months) | Subjects ≥6 to <24 months of age who received aQIV |
| OG003 | TIV/QIV (≥6 to <24 Months) | Subjects ≥6 to <24 months of age who received TIV/QIV |
| OG004 | aQIV (≥6 to <36 Months) | Subjects ≥6 to <36 months of age who received aQIV |
| OG005 | TIV/QIV (≥6 to <36 Months) | Subjects ≥6 to <36 months of age who received TIV/QIV |
| OG006 | aQIV (≥36 to <72 Months) | Subjects ≥36 to <72 months of age who received aQIV |
| OG007 | TIV/QIV (≥36 to <72 Months) | Subjects ≥36 to <72 months of age who received TIV/QIV |
|
|
| TIV/QIV (≥6 to <72 Months) |
Subjects ≥6 to <72 months of age who received TIV/QIV: Healthy and at-risk |
|
|
|
|
Subjects ≥6 to <72 months of age who received TIV/QIV
|
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
Healthy subjects ≥6 to <72 months of age who received TIV/QIV |
| OG003 | TIV/QIV (≥6 to <72 Months) - High Risk | High risk subjects ≥6 to <72 months of age who received TIV/QIV |
|
|
|
| OG001 | TIV/QIV (≥6 to <72 Months) | Subjects ≥6 to <72 months of age who received TIV/QIV |
|
|
| OG001 |
| TIV/QIV (≥6 to <72 Months) |
Subjects ≥6 to <72 months of age who received TIV/QIV |
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
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| Participants |
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|
|
|
|